Retiro De Equipo (Recall) de GE Precision 500D

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por GE Healthcare.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    49388
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1477-2008
  • Fecha de inicio del evento
    2007-08-13
  • Fecha de publicación del evento
    2008-09-18
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2010-10-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Image-intensified fluoroscopic x-ray system. - Product Code JAA
  • Causa
    Necessary certification labels are missing from the x-ray contol.
  • Acción
    A field Engineer from GE will visit the customer site to apply label to the X-ray control.

Device

  • Modelo / Serial
    serial numbers: 00001014958WK1, 100963570, 00000086203DP7, 00000086475DP1, 00000086507DP1, 00000089131DP7, 00000993365WK6, 00000994505WK6, 00000995353WK0, 00000996209WK3, 00000996212WK7, 00000996789WK4, 00001000009WK9, 00001002273WK9, 00001002491WK7, 00001009077WK7, 00001009774WK9, 00001009986WK9, 00001010013WK9, 00001010015WK4, 00001010016WK2, 00001010017WK0, 00001010018WK8, 00001010020WK4, 00001010021WK2, 00001010059WK2, 00001010060WK0, 00001010061WK8, 00001010062WK6, 00001010063WK4, 00001010064WK2, 00001010065WK9, 00001010066WK7, 00001010068WK3, 00001010091WK5, 00001010120WK2, 00001010208WK5, 00001010209WK3, 00001010210WK1, 00001010212WK7, 00001010213WK5, 00001010214WK3, 00001010216WK8, 00001010217WK6, 00001010287WK9, 00001010328WK1, 00001010329WK9, 00001010330WK7, 00001010333WK1, 00001010334WK9, 00001010335WK6, 00001010336WK4, 00001010337WK2, 00001010550WK0, 00001010551WK8, 00001010552WK6, 00001010553WK4, 00001010554WK2, 00001010555WK9, 00001010739WK9, 00001010741WK5, 00001010743WK1, 00001010744WK9, 00001010746WK4, 00001010747WK2, 00001010748WK0, 00001010854WK6, 00001010855WK3, 00001010856WK1, 00001010859WK5, 00001010860WK3, 00001010861WK1, 00001010862WK9, 00001010863WK7, 00001011010WK4, 00001011011WK2, 00001011012WK0, 00001011013WK8, 00001011014WK6, 00001011029WK4, 00001011030WK2, 00001011031WK0, 00001011033WK6, 00001011035WK1, 00001011036WK9, 00001011037WK7, 00001011200WK1, 00001011201WK9, 00001011202WK7, 00001011203WK5, 00001011204WK3, 00001011205WK0, 00001011206WK8, 00001011207WK6, 00001011208WK4, 00001011209WK2, 00001011320WK7, 00001011321WK5, 00001011327WK2, 00001011328WK0, 00001011341WK3, 00001011342WK1, 00001011343WK9, 00001011344WK7, 00001011345WK4, 00001011346WK2, 00001011347WK0, 00001011348WK8, 00001011349WK6, 00001011513WK7, 00001011514WK5, 00001011515WK2, 00001011516WK0, 00001011517WK8, 00001011518WK6, 00001011519WK4, 00001011520WK2, 00001011521WK0, 00001011657WK2, 00001011762WK0, 00001011763WK8, 00001011764WK6, 00001011765WK3, 00001011766WK1, 00001011767WK9, 00001011768WK7, 00001011769WK5, 00001011770WK3, 00001011875WK0, 00001011876WK8, 00001011877WK6, 00001011878WK4, 00001011879WK2, 00001011887WK5, 00001011888WK3, 00001011889WK1, 00001011890WK9, 00001011891WK7, 00001012024WK4, 00001012025WK1, 00001012026WK9, 00001012027WK7, 00001012028WK5, 00001012029WK3, 00001012030WK1, 00001012031WK9, 00001012032WK7, 00001012033WK5, 00001012176WK2, 00001012177WK0, 00001012178WK8, 00001012179WK6, 00001012180WK4, 00001012181WK2, 00001012182WK0, 00001012183WK8, 00001012186WK1, 00001012187WK9, 00001012188WK7, 00001012189WK5, 00001012190WK3, 00001012191WK1, 00001012192WK9, 00001012193WK7, 00001012194WK5, 00001012195WK2, 00001012432WK9, 00001012434WK5, 00001012435WK2, 00001012499WK8, 00001012500WK3, 00001012501WK1, 00001012502WK9, 00001012503WK7, 00001012505WK2, 00001012506WK0, 00001012508WK6, 00001012541WK7, 00001012542WK5, 00001012543WK3, 00001012546WK6, 00001012547WK4, 00001012548WK2, 00001012549WK0, 00001012881WK7, 00001012883WK3, 00001012884WK1, 00001012885WK8, 00001012888WK2, 00001012889WK0, 00001012991WK4, 00001012992WK2, 00001012993WK0, 00001012995WK5, 00001012996WK3, 00001012997WK1, 00001013087WK0, 00001013088WK8, 00001013089WK6, 00001013090WK4, 00001013102WK7, 00001013176WK1, 00001013177WK9, 00001013178WK7, 00001013179WK5, 00001013181WK1, 00001013182WK9, 00001013183WK7, 00001013184WK5, 00001013185WK2, 00001013293WK4, 00001013294WK2, 00001013298WK3, 00001013299WK1, 00001013302WK3, 00001013576WK2, 00001013577WK0, 00001013578WK8, 00001013579WK6, 00001013580WK4, 00001013581WK2, 00001013582WK0, 00001013583WK8, 00001013584WK6, 00001013585WK3, 00001013726WK3, 00001013728WK9, 00001013729WK7, 00001013731WK3, 00001013732WK1, 00001013733WK9, 00001013734WK7, 00001013735WK4, 00001013968WK1, 00001013969WK9, 00001013970WK7, 00001013974WK9, 00001013976WK4, 00001013977WK2, 00001014092WK9, 00001014093WK7, 00001014095WK2, 00001014097WK8, 00001014098WK6, 00001014099WK4, 00001014279WK2, 00001014280WK0, 00001014392WK3, 00001014394WK9, 00001014395WK6, 00001014397WK2, 00001014398WK0, 00001014549WK8, 00001014550WK6, 00001014551WK4, 00001014553WK0, 00001014556WK3, 00001014702WK3, 00001014703WK1, 00001014704WK9, 00001014705WK6, 00001014706WK4, 00001014707WK2, 00001014710WK6, 00001014711WK4, 00001014866WK6, 00001014953WK2, 00001014959WK9, 00001014960WK7, 00001014961WK5, 00001014962WK3, 00001015088WK6, 00001015092WK8, 00001015093WK6, 00001015096WK9, 00001015219WK7, 00001015220WK5, 00001015292WK4, 00001015293WK2, 00001015295WK7, 00001015297WK3, 00001015298WK1, 00001015559WK6, 00001015563WK8, 00001015689WK1, 00002AU53105K0, 00002UA4490WQG, 00002UA4490WQM, 00002UA4490WQV, 00002UA4510C3B, 00002UA4510C3J, 00002UA45200NH, 00002UA45200NM, 00002UA45200NR, 00002UA45200QY, 00002UA50306KL, 00002UA50306KT, 00002UA50306KW, 00002UA50306L6, 00002UA50306L7, 00002UA50306L8, 00002UA50306LD, 00002UA5030PTY, 00002UA5030PTZ, 00002UA5030PV2, 00002UA5040SH5, 00002UA504DSH3, 00002UA504OSH5, 00002UA5050FP7, 00002UA5080W88, 00002UA5080W89, 00002UA5100TCV, 00002UA510147Y, 00002UA51411JC, 00002UA51411JF, 00002UA51411JG, 00002UA51411JM, 00002UA51411JN, 00002UA51411JT, 00002UA51411JY, 00002UA51411JZ, 00002UA51604QS, 00002UA51604QV, 00002UA51604QY, 00002UA51604R2, 00002UA51604R3, 00002UA51604R4, 00002UA51604R6, 00002UA51604R9, 00002UA51604RH, 00002UA51701BZ, 00002UA51701C2, 00002UA51701C5, 00002UA51701C6, 00002UA51701C8, 00002UA51701CH, 00002UA52111XQ, 00002UA52111XR, 00002UA52111XS, 00002UA52111XT, 00002UA52111XV, 00002UA52111XW, 00002UA52111XX, 00002UA5220564, 00002UA5220BKM, 00002UA5220BKP, 00002UA5220BKV, 00002UA5220S5X, 00002UA5220S5Y, 00002UA5220S5Z, 00002UA5220S62, 00002UA5220S63, 00002UA52606Q5, 00002UA52606QC, 00002UA52606QD, 00002UA52707GY, 00002UA52707GZ, 00002UA527115R, 00002UA527115V, 00002UA527115Z, 00002UA5290DD1, 00002UA5290DD2, 00002UA53006LM, 00002UA53006LN, 00002UA53006LP, 00002UA53006LR, 00002UA53006LS, 00002UA53006LT, 00002UA53006LV, 00002UA5320FKJ, 00002UA5320FKM, 00002UA5320FKN, 00002UA5320FKR, 00002UA53405P5, 00002UA53405P7, 00002UA53405P9, 00002UA53405PG, 00002UA5340LCV, 00002UA5340LCY, 00002UA5340VDC, 00002UA5340VDG, 00002UA5340VDK, 00002UA5340VDL, 00002UA535112H, 00002UA5360CBD, 00002UA5360CBG, 00002UA5360CBM, 00002UA5360CBN, 00002UA53707WM, 00002UA53707WQ, 00002UA53707WR, 00002UA53802GP, 00002UA5400VB7, 00002UA5400VB8, 00002UA541113W, 00002UA541113X, 00002UA5411140, 00002UA5411142, 00002UA5411143, 00002UA5411144, 00002UA5411146, 00002UA5411147, 00002UA5411148, 00002UA5411149, 00002UA541114B, 00002UA541114H, 00002UA542046N, 00002UA542046P, 00002UA542046Q, 00002UA542046R, 00002UA542046T, 00002UA542046V, 00002UA5420VPK, 00002UA5420VPM, 00002UA5420VPP, 00002UA5430X4Y, 00002UA5440B2V, 00002UA5440B2W, 00002UA5450SNN, 00002UA5450SNR, 00002UA5450SNY, 00002UA60200GH, 00002UA606KJH4, 00002UA606KJH7, 00002UA615JV3C, 0000USU4350N51, 0000USU4400NXF, 0000USU4400NXJ, 0000USU4400NXQ, 0000USU4400NXV, 0000USU4400NXW, 0000USU4400NXY, 0000USU4400NY0, 00010103324WK3, 0UNK2289299-01, , 00000114134VE0.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide including USA and countries of Italy, Japan, Spain, and Turkey.
  • Descripción del producto
    GE Precision 500D, model 2403790-3, Radiographic and Fluoroscopic Systems. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188, U.S.A.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    GE Healthcare, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA